Advanced Solid TumorsK-PRECISIONNCT07891169
Master Protocol for Basket Clinical Trials of Targeted Therapies Based on Proteome and Whole Exome Sequencing Screening in Patients With Advanced Solid Tumors
A study testing Homologous Recombination Deficiency (HRD) and ALK/ROS1/MET in people with Advanced Solid Tumors and Metastatic Solid Tumors, run by National Cancer Center, Korea at 2 sites in South Korea.
Trial summary
Study Overview This study evaluates a proteogenomic screening platform to identify precise therapeutic targets for patients with advanced solid tumors. While traditional precision medicine relies on DNA sequencing (genomics), this research adds protein analysis (proteomics) to better understand how cancer cells… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Advanced Solid Tumors, Metastatic Solid Tumors, Locally Advanced Solid Tumors
- What is being tested?
- Homologous Recombination Deficiency (HRD) and ALK/ROS1/MET
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,800 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 18 Nov 2024to 31 Dec 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has voluntarily provided written informed consent.
- Subject is 19 years of age or older.
- Histologically or cytologically confirmed metastatic or locally advanced solid tumor.
- Stage III or higher, Stage IV, or patients determined by the investigator to have a high risk of future recurrence.
- Life expectancy of ≥ 3 months.
- ECOG Performance Status of 0-2.
Who cannot join
- Serious or unstable pre-existing medical or psychiatric conditions that, in the investigator's judgment, could compromise subject safety during the master protocol or subsequent basket trials.
- Cognitive impairment or a diagnosis of dementia that may impede the subject's ability to participate safely.
- Inability to obtain sufficient tumor specimens for required proteogenomic analysis.
- Refusal to consent specifically to the proteogenomic testing component of the study.
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
National Cancer Center, Korea
Goyang, Gyeonggido, 10408
National Cancer Center, Korea
Goyang-si, Gyeonggido, 10408
About this study
Study Overview This study evaluates a proteogenomic screening platform to identify precise therapeutic targets for patients with advanced solid tumors. While traditional precision medicine relies on DNA sequencing (genomics), this research adds protein analysis (proteomics) to better understand how cancer cells function and respond to treatment.
- Background and Purpose Standard genomic testing often fails to predict whether a patient will respond to a specific drug because DNA mutations do not always result in active protein expression. By integrating Whole Exome Sequencing (WES) with phosphoproteomics (the study of protein activation), this study aims to:
Read more
- Identify active signaling networks that DNA testing alone might miss.
- Evaluate the feasibility and cost-effectiveness of this integrated platform compared to traditional methods.
- Help match patients to the most effective targeted therapies through a "Basket Trial" framework, where treatment is based on molecular signatures rather than where the cancer started in the body.
- Target Population
- Adults (19 years and older) with histologically confirmed metastatic or locally advanced solid tumors.
- Patients with Stage III, IV, or those at a high risk of recurrence.
- Participants must have a life expectancy of at least 3 months and a good performance status (ECOG 0-2).
- Study Procedures
- Specimen Collection: Researchers will collect tumor tissue through biopsy or surgery. To preserve the integrity of proteins, these samples must be snap-frozen (Fresh-Frozen) immediately after extraction.
- Analysis: The study will analyze the tissue and blood samples to characterize the patient's unique proteogenomic profile.
- Treatment Assignment: If a specific molecular variant is identified (such as HRD or ALK/ROS1/MET signatures), and a matching sub-protocol is available, the patient may be enrolled in a targeted therapy trial. Patients who do not meet these criteria will continue with the standard of care.
- Expectations and Logistics This is a multicenter, prospective screening study involving a nationwide logistics system to ensure high-quality sample transport. The study aims to enroll a total of 2,800 subjects (approximately 560 per year) and is expected to continue through December 31, 2028.
- Potential Benefits and Risks
- Benefits: Participants may gain access to targeted therapies based on their cancer's specific molecular profile.
- Risks: While the study does not add new invasive procedures beyond standard care, there are potential psychosocial risks related to genomic findings and the sharing of de-identified data for research purposes.
Read the detailed description
- 1. Scientific Rationale and the Proteogenomic Approach While genomic sequencing has become a cornerstone of precision oncology, it frequently lacks the resolution to predict functional therapeutic responses. This is evidenced by clinical outcomes where DNA-level mutations do not always translate to functional protein expression or are bypassed by alternative signaling pathways. To address these limitations, this study implements a proteogenomic approach that integrates Whole Exome Sequencing (WES) with high-efficiency phosphoproteomic analysis. By identifying active signaling networks and protein overexpressions that DNA sequencing alone overlooks, the platform aims to improve treatment assignment and evaluate the cost-effectiveness of this integrated screening compared to traditional methods.
- 2. Specimen Integrity and Logistics A critical technical requirement for high-fidelity phosphoproteomics is the use of fresh-frozen (FF) tissue, as standard formalin-fixed paraffin-embedded (FFPE) samples are unsuitable for analyzing protein phosphorylation states. Adhering to standards established by the US NCI Clinical Proteomic Tumor Analysis Consortium (CPTAC), this study utilizes snap-frozen specimens. A secondary objective of this protocol is the establishment of a nationwide logistics system to transport these FF specimens while strictly maintaining a target Cold Ischemia Time (CIT)-the interval from extraction to freezing-to ensure molecular integrity.
- 3. Study Framework: Master Protocol and Sub-protocols This study serves as a "Basket Trial" framework. It is a multicenter, prospective screening study designed to identify molecular signatures rather than focusing on the anatomical site of the primary tumor. The study workflow is as follows:
- Screening: Proteogenomic screening may be performed at any point following the diagnosis of advanced/metastatic disease or during first-line therapy.
- Analysis Tiers: The analysis includes Tandem Mass Tag (TMT) labeling for quantitative profiling of active signaling networks and WES on tumor tissue with paired blood samples to differentiate germline variants from somatic mutations. In select cases, fresh tissue is used for functional validation through in vitro cell culture and in vivo Patient-Derived Xenograft (PDX) modeling.
- Transition to Treatment: Upon identification of target molecular variants (such as Homologous Recombination Deficiency (HRD) or ALK/ROS1/MET signatures) and disease progression after standard therapy, subjects may be enrolled in independent Phase 1 or 2 sub-protocols. Subjects who do not meet specific molecular criteria will continue to receive the standard of care.
- 4. Scale and Ethical Standards The study aims to enroll 2,800 subjects over a 5-year duration, leveraging the collective capacity of multiple regional coordinating centers across the Republic of Korea. The protocol is conducted in accordance with the Declaration of Helsinki and Korean Good Clinical Practice (KGCP). All research data is pseudonymized to ensure subject privacy and confidentiality.
- Conditions
- Advanced Solid Tumors, Metastatic Solid Tumors, Locally Advanced Solid Tumors, Recurrent Solid Tumors, Proteogenomic Screening and Molecular Signaling, Basket Clinical Trial Framework
- Being tested
- Homologous Recombination Deficiency (HRD), ALK/ROS1/MET, standard care treatment
- Keywords
- Proteogenomics, Whole Exome Sequencing (WES), Tandem Mass Tag (TMT) labeling, Molecular Profiling, Master Protocol, Basket Trial, Precision Medicine, Multicenter Screening Study, Advanced Solid Tumors, Homologous Recombination Deficiency (HRD, ALK / ROS1 / MET, Targeted Therapy, Fresh-Frozen (FF) Specimens, Cold Ischemia Time (CIT), Nationwide Logistics System
- Medical subject headings
- Kenny-Caffey syndrome, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Homologous Recombination Deficiency (HRD)Drug
This arm consists of subjects identified with Homologous Recombination Deficiency (HRD)-positive proteogenomic signatures through the master screening protocol
. These subjects are eligible for matching targeted therapy sub-protocols
ALK/ROS1/METDrug
ALK/ROS1/MET-targeted therapy (Crizotinib 250mg )
standard care treatmentDrug
This arm is for subjects who do not meet the specific molecular criteria for the available targeted sub-protocols following proteogenomic screening
. These subjects will continue to receive the standard-of-care treatment at their respective institutions
| Study group | Role | What they receive |
|---|---|---|
| HRD-Positive Targeted Therapy Arm | Experimental | HRD-targeted therapy (for Homologous Recombination Deficiency-positive signatures) (Nesuparib, Cisplatin) Receives: Drug: Homologous Recombination Deficiency (HRD) |
| ALK/ROS1/MET Targeted Therapy Arm | Experimental | ubjects with specific ALK, ROS1, or MET gene variants or protein overexpression identified through proteogenomic analysis Receives: Drug: ALK/ROS1/MET |
| Standard Care Arm | Other | Routine oncological treatments administered according to institutional guidelines for patients whose proteogenomic profile does not match a specific study sub-protocol Receives: Drug: standard care treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Successful Identification of Actionable Therapeutic Targets
The percentage of subjects whose proteogenomic profiles-characterized through integrated Whole Exome Sequencing (WES) and phosphoproteomic analysis of fresh-frozen (FF) specimens-allow for the identification of actionable therapeutic targets for enrollment in specific basket trial sub-protocols (e.g., HRD or ALK/ROS1/MET)
Measured: From the date of pre-treatment tissue sample collection until the completion of proteogenomic analysis and report generation, assessed up to 3 weeks (21 days) per participant.
Secondary outcomes (3)
Logistical Success Rate of Fresh-Frozen (FF) Specimen Transport
The proportion of collected specimens that successfully meet the strict Cold Ischemia Time (CIT) requirements (the interval from extraction to freezing) as part of the established nationwide delivery and logistics system
Measured: From the time of tissue collection at participating hospitals until receipt and quality control verification at the central biobank, assessed up to 14 days per specimen.
Progression-Free Survival (PFS) and Overall Survival (OS)
Evaluation of survival outcomes relative to the identified proteogenomic profiles and subsequent treatment assignments using Kaplan-Meier estimates and Cox-proportional hazards regression
Measured: From enrollment until disease progression or death from any cause, whichever occurs first, assessed up to 5 years.
Frequency and Distribution of Molecular Signature
Descriptive characterization of the frequency of targetable molecular variants and proteogenomic signatures across various advanced solid tumor types
Measured: From enrollment through completion of molecular signature profiling for all participants, assessed up to 36 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study start18 Nov 2024
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Young-Woo Kim, National Cancer Center, Korea
- Investigators
- Young-Woo Kim, Principal investigator, National Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07891169
- Sponsor's protocol ID
- NCC2024-0302
- Other IDs
- 24H1640
- Acronym
- K-PRECISION
- Status last verified
- Oct 2026
- First submitted
- 7 Oct 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Bedard PL, Li S, Wisinski KB, Yang ES, Limaye SA, Mitchell EP, Zwiebel JA, Moscow JA, Gray RJ, Wang V, McShane LM, Rubinstein LV, Patton DR, Williams PM, Hamilton SR, Conley BA, Arteaga CL, Harris LN, O'Dwyer PJ, Chen AP, Flaherty KT. Phase II Study of Afatinib in Patients With Tumors With Human Epidermal Growth Factor Receptor 2-Activating Mutations: Results From the National Cancer Institute-Molecular Analysis for Therapy Choice ECOG-ACRIN Trial (EAY131) Subprotocol EAY131-B. JCO Precis Oncol. 2022 Jul;6:e2200165. doi: 10.1200/PO.22.00165.
PubMed 35939768Zhang H, Liu T, Zhang Z, Payne SH, Zhang B, McDermott JE, Zhou JY, Petyuk VA, Chen L, Ray D, Sun S, Yang F, Chen L, Wang J, Shah P, Cha SW, Aiyetan P, Woo S, Tian Y, Gritsenko MA, Clauss TR, Choi C, Monroe ME, Thomas S, Nie S, Wu C, Moore RJ, Yu KH, Tabb DL, Fenyo D, Bafna V, Wang Y, Rodriguez H, Boja ES, Hiltke T, Rivers RC, Sokoll L, Zhu H, Shih IM, Cope L, Pandey A, Zhang B, Snyder MP, Levine DA, Smith RD, Chan DW, Rodland KD; CPTAC Investigators. Integrated Proteogenomic Characterization of Human High-Grade Serous Ovarian Cancer. Cell. 2016 Jul 28;166(3):755-765. doi: 10.1016/j.cell.2016.05.069. Epub 2016 Jun 29.
PubMed 27372738Mertins P, Mani DR, Ruggles KV, Gillette MA, Clauser KR, Wang P, Wang X, Qiao JW, Cao S, Petralia F, Kawaler E, Mundt F, Krug K, Tu Z, Lei JT, Gatza ML, Wilkerson M, Perou CM, Yellapantula V, Huang KL, Lin C, McLellan MD, Yan P, Davies SR, Townsend RR, Skates SJ, Wang J, Zhang B, Kinsinger CR, Mesri M, Rodriguez H, Ding L, Paulovich AG, Fenyo D, Ellis MJ, Carr SA; NCI CPTAC. Proteogenomics connects somatic mutations to signalling in breast cancer. Nature. 2016 Jun 2;534(7605):55-62. doi: 10.1038/nature18003. Epub 2016 May 25.
PubMed 27251275Savage SR, Yi X, Lei JT, Wen B, Zhao H, Liao Y, Jaehnig EJ, Somes LK, Shafer PW, Lee TD, Fu Z, Dou Y, Shi Z, Gao D, Hoyos V, Gao Q, Zhang B. Pan-cancer proteogenomics expands the landscape of therapeutic targets. Cell. 2024 Aug 8;187(16):4389-4407.e15. doi: 10.1016/j.cell.2024.05.039. Epub 2024 Jun 24.
PubMed 38917788Zhang B, Wang J, Wang X, Zhu J, Liu Q, Shi Z, Chambers MC, Zimmerman LJ, Shaddox KF, Kim S, Davies SR, Wang S, Wang P, Kinsinger CR, Rivers RC, Rodriguez H, Townsend RR, Ellis MJ, Carr SA, Tabb DL, Coffey RJ, Slebos RJ, Liebler DC; NCI CPTAC. Proteogenomic characterization of human colon and rectal cancer. Nature. 2014 Sep 18;513(7518):382-7. doi: 10.1038/nature13438. Epub 2014 Jul 20.
PubMed 25043054